FDA Approves Anti-Psoriasis Spray

The FDA has granted approval for betamethasone diproprionate (Sernivo Spray/ Dr. Reddy-Promius Pharma) to treat mild-to-moderate plaque psoriasis in patients at least 18 years of age.

To assess the safety and efficacy of Sernivo Spray, Promius conducted two randomized, double-blind clinical trials with plaque psoriasis patients 18 years or older.

Both trials randomized patients to administer Sernivo Spray or a placebo spray on their affected areas of skin twice daily for 28 days.

Results indicated significantly more patients in the Sernivo Spray group saw treatment success at both days 15 and 29. Furthermore, at day 29, in both studies, Sernivo Spray achieved 42.7% and 34.5% treatment success compared to the 11.7% and 13.6% success rates in the control spray, respectively.

G V Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories commented in a news release, “The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch. We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market.”

The prescription topical steroid is slated for commercial launch for the upcoming quarter.